欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号MT/H/0664/002
药品名称Sitagliptin/Metformin Biofarmoz 50 mg/1000 mg film-coated tablets
活性成分
    • Metformin hydrochloride 1000.0 mg
    • sitagliptin hydrochloride monohydrate 50.0 mg
剂型Film-coated tablet
上市许可持有人Biofarmoz - Sociedade Técnico Medicinal, Unipessoal Lda. Rua da Tapada Grande nº 2, Abrunheira, Sintra 2710-089 Portugal
参考成员国 - 产品名称Malta (MT)
Sitagliptin/Metformin Biofarmoz 50 mg/1000 mg film-coated tablets
互认成员国 - 产品名称
    • Spain (ES)
    • Portugal (PT)
许可日期2023/10/04
最近更新日期2025/01/22
药物ATC编码
    • A10BD07 metformin and sitagliptin
申请类型
  • TypeLevel1：Known Active Substance
  • TypeLevel2：Initial Application
  • TypeLevel3：Generic Art 10.1 and 10.2 Dir 2001/83/EC
  • TypeLevel4：Chemical Substance
  • TypeLevel5：Prescription Only
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市场状态Positive
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